The present invention relates to an electrode package and a method for sealing same. Specifically it pertains to an electrode package containing electrodes having wires which extend through the wall of the package to the exterior of the package, and having a unique seal at the point where the wires pass through the wall of the package.
Physiological electrodes have been used for various functions, including defibrillating patients whose hearts are in fibrillation, monitoring the heart beat of patients, pacing the heart beat of patients, and other types of heart and muscle stimulation. The electrodes generally are placed on the chest of the patient and include wires extending to a console which controls the particular function desired.
These electrodes are stored in hermetically sealed packages so as to maintain their performance until the time of use. At the time of use, the person applying the electrodes must tear open the package, remove the electrodes from the package, place them on the patient's chest, and plug the wire into the console.
Because time is often critical, particularly in cases where the patient is encountering fibrillation, it is desirable to reduce the time necessary to remove the electrodes from the package and make them operable.
One way of reducing the time necessary to make the electrodes operable is to provide a package having the electrodes within the package, but having the wires extending through the walls of the package to a plug which is outside the package. This enables the operator to plug the plug into the console before an emergency arises. Then when the electrodes are needed, the operator need only tear open the package, pull the electrodes out of the package and place them on the chest of the patient. Because the wires are already plugged into the console, the system is ready for defibrillation or monitoring or any other function needed.
Extending the wires through the hermetically sealed package, while at the same time maintaining the hermetic seal of the package, presents a difficult problem, particularly in the manufacture of the packaged electrode. Different methods have been tried for providing a proper seal. One method is to make the package from two facing sheet members that are sealed around their perimeters. The wire is extended through the seal, and a paper and glue seal are manually fused around the point where the wires extend out of the package. Manual application of the paper and glue to the seal, together with the required heating and curing of the glue, consume a considerable amount of time during manufacture, and therefore increase the price of the electrodes substantially.
Another prior art method used for creating a seal is to place a plastic member, called a football, around the wires. Then the football is placed between the sheet members of the pouch at the point where the wires exit the pouch. The football is presealed around the wires initially, and after it is placed between the sheet members, heat and pressure are applied to provide a seal between the football and the two sheet members. While this particular method is less time consuming, it is more expensive because it requires the cost of the football, an added part, and because it requires the football to be presealed around the wires, thereby adding an additional step to the sealing process.
Therefore a primary object of the present invention is the provision of an improved electrode package and method for sealing same.
A further object of the present invention is the provision of an improved seal around the wires as they pass through the electrode package without requiring additional parts such as a sealing football, and without requiring the need of a special paper and glue seal.
A further object of the present invention is the provision of an electrode package and method for sealing same which provides a seal where the wires exit the package within a minimum amount of time.
A further object of the present invention is the provision of an improved seal where the wires exit the package which utilizes the inherent materials of the package and the wire insulation to create a seal.
A further object of the present invention is the provision of an improved electrode package and method for sealing same which requires merely the application of heat and pressure to create the seal.
A further object of the present invention is the provision of an improved electrode package and method for sealing same which involves simple and efficient means of manufacture and which is durable in use.